A person is said to have an allergy when their immune system overreacts to the presence of a substance (an allergen) that is not normally considered to be of danger to the body. When a person becomes hypersensitive to one or more allergens, the body assumes it is being invaded and calls up the defense forces to neutralize the offending substance. Allergy is defined as an “abnormal hypersensitivity to a substance which is normally tolerated and generally considered harmless.” Unfortunately, the release of histamine during this response produces unwelcome symptoms such as sneezing, runny or stuffed nose, itchy eyes, breathing difficulties, and, in extreme cases, anaphylactic shock and death.
Autoimmune disease affects an estimated 50 million people at an annual cost of more than $100 billion and the suffering and monetary costs are sure to grow. The prevalence of allergic disease and asthma increased between two- and threefold in the late 20th century, a mysterious trend often called the “allergy epidemic.” It is believed that highly hygienic environments, especially in infancy, play an important role in the skyrocketing occurrence of asthma, allergies and autoimmune disease.
One medically accepted treatment for allergies is immunotherapy. Immunotherapy involves the repeated injection of allergen extracts to desensitize a patient to the allergen. Traditional immunotherapy is time consuming, usually involving years of treatment, and often fails to achieve its goal of desensitizing the patient to the allergen. Furthermore, it is not the recommended treatment for food allergies, such as peanut allergies, due to the risk of anaphylaxis, a systemic and potentially lethal.
It has been observed that children born to mothers who work with livestock while pregnant, and who lug their newborns along during chores, seem the most invulnerable to allergic disease later. It has also been observed that there are differences in the placentas of children who later develop allergies such that a critical subset of white blood cells—called regulatory T-cells—seems relatively scarce at birth. It is suspected that a healthy population of these and other “suppressor” cells is important in preventing allergies and asthma. Evidence exists that European farming children are born with a comparative surfeit of these cells. Other findings report that farming newborns have more regulatory T-cells in cord blood than babies of nonfarmers. Moreover, it has been observed that such suppressive ability increases with the number of different types of animals the mother tended while pregnant.
Confusingly, however, it has also been observed that occasional visits to the farm may exacerbate allergic propensities, thus those who believed that simply taking a family outing to a farm would somehow ameliorate allergies has not proven to be effective.
Isolation of the curative agents at issue for allergies has thus far eluded top scientists and researchers. In the meantime, expectant mothers are desperate to do something, but unsure of what to do in a culture that touts a “cleanliness is good” ethos instilled in the developed world—but at the same time stressing the protection of mothers and children from terrible diseases caused by the filthy habitats that exist in underdeveloped regions of the globe.
There is increasing evidence that many aspects of health and disease are determined not only during infancy, but also during pregnancy. This is especially true with allergic disease, where immune responses at birth implicate intrauterine exposure as a primary sensitization event. It has been shown that the human fetus develops IgE-producing B cells early in gestation and is capable of producing IgE antibodies in response to appropriate antigenic stimuli in a manner analogous to the well-recognized IgM responses that are observed in various prenatal infections. Others have documented the various empirical evidence that exposures to various agents has a profound impact on a human's development of a healthy immune system, free of allergies and autoimmune diseases, collectively sometimes referred to as the “hygiene hypothesis.” See e.g. Velasquez-Manoff, “An Epidemic of Absence.”
The largest microbial community in the human body resides in the gut and comprises somewhere between 300 and 1000 different microbial species. The human body, consisting of about 100 trillion cells, carries about ten times as many microorganisms in the intestines. The gut microbiome contains at least two orders of magnitude more genes than are found in the Homo sapiens genome.
The laudable goal of discovering the secret in the immunity benefits of living on a farm has occupied countless hours of skilled and talented individuals and frustrated those experts in the field whose lives are dedicated to discovering the cause of the acquired immunity, and to then bottle up the cure and provide it to the increasing masses of urban dwellers. This objective has been as sought after as it has proven elusive. In the meantime, the rise in allergies increases without abatement and children are daily diagnosed with life threatening allergic conditions that defy explanation. This presents, therefore, a classic case of a long felt but unsolved need, made all the more compellingly frustrating by having the apparent effective agent that confers immunity—present just miles away from city centers: on the farm.
The present inventors submit that in the interim period before the precise agents that confer immunity are discovered and isolated, it is important for expectant mothers to be comfortable with being provided with an effective composition without knowing precisely what agent or agents is responsible for such benefit. It may take decades for such determinants to be “discovered” and isolated. But the lives and tremendous emotional, financial and human capital expended—as well as lives lost—is too precious to simply await the ultimate elucidation of the cure—or at least effective refined treatment of a select agent that confers the desired immunologic factors to a person, and especially to a fetus.
There is therefore a need for a treatment that can be made available to city dweller expectant mothers so that their unborn babies have a significant opportunity to develop immunity to life threatening allergies and other autoimmune diseases in later life. And in addition to food allergies, there is a need to understand and address other autoimmune diseases including type 1 diabetes, Crohn's disease, multiple sclerosis, Alzheimer's, asthma, autism, inflammatory arthritis, lupus, lupus erythermatosis, juvenile rheumatoid arthritis, immune cancers, inflammatory bowel disease, ulcerative colitis, allergic rhinitis, celiac disease, obesity, and oesophageal reflux. The present inventors disclose treatments that are fashioned to avoid and prevent, but at least to reduce, the occurrence of devastating diseases that can be traced back to a particular point in a person's developing immune system—where the absence of particular agents at such a critical time period can be seen as responsible for a failure to develop a better, more disease protective immune system. Such a treatment would preferably be relatively inexpensive, as expectant mothers are often young and without significant resources. It should be available in a fashion that they can be exposed to the immunologic agents in a fashion that does not depend upon their dutiful regimen of taking some medication or treatment—and thus, a system and method that exposes them to the treatment without a daily calendar of duties would be preferred. It would preferably be simple, economical and effective without interfering significantly with the expectant mothers otherwise busy and—by the nature of pregnancy—worrisome, hormonal and often challenging time period in life, with job and family and health issues seemingly changing on a daily basis as their belly grows.